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Indians: The most preferred guinea pigs?
Thanks to a pliant bureaucracy and our own poverty-stricken and ignorant masses, foreign drug manufacturers do not find it difficult to trap patients who can be used as guinea pigs to test the efficacy and safety aspects of their drugs.

A SHOCKING report from the All India Institute of Medical Sciences (AIIMS) leaves us wondering whether we can entrust our children to the care of our health sector. The said report states that 49 babies, all below one year of age, have died in AIIMS because new drugs and therapies were tested on them over the last two years and a half. This information was obtained by Rahul Varma of ‘Uday Foundation for Congenital Defects and Rare Blood Groups’, under the provisions of the Right to Information Act (RTI). He sought the report because some of the parents were unable to admit their seriously-ill children to AIIMS while ironically, children from some poor and illiterate families were treated at the hospital for too long a time. According to the report, 4142 babies, of which 2,728 were below the age of one, were registered for clinical trials by the institutes’ department of paediatrics. 49 babies had died since January 1, 2007. During this period, the department had conducted 42 sets of trials on babies. On August 18, Health minister Anbumani Ramadoss, after a meeting of the governing body, asked the IIMS director to conduct an inquiry and submit a report as soon as possible on the whole issue. But the question is who will be ultimately held responsible for the death of the 49 babies.

First of all, there is the question of ethics underlying the said clinical trials. A clinical trial is the ultimate stage of the research. It is conducted to answer questions on the safety and efficacy aspects of vaccines, drugs, devices, new therapies and forms of care or new ways of using known treatments. In brief, each study attempts to find better ways to prevent, diagnose and treat diseases. The most notable thing is that, in India, many of these trials are conducted using foreign drugs. It is only recently that India became Asia’s most admired destination for conducting clinical trials. According to statistics released by the Planning Board, 139 new trials were outsourced to India recently. This is not only because it is cheaper but also because it is easy to deceive the system in India, given that most of the trials are conducted on the poor. It is a fact that India sources life-saving drugs from foreign countries. Importers of such drugs do not print the price of the drugs on the package, thanks to the loopholes in our law. Retailers cannot afford to stock such costly drugs. So corporate giants like Subiksha, Reliance and Pantaloon (many of them already have retail outlets in many states) are free to sell the said drugs at any price they choose. Besides, the Centre has allowed drug manufacturers the freedom to price 70 per cent of their products. In the case of the remaining 30 percent of products, the price is decided by the government. So the absence of a regulator has led to a proliferation of spurious drugs.

The Masheedkar Commission, appointed in 2007 to detect spurious drugs in the country, reported that except in Kerala and Goa, the health sector in most of the states was characterised by spurious drugs. The AIIMS issue also points to the presence of fake drugs. Five foreign-manufactured drugs were tested during the trials at AIIMS. They were Zinc tablets serving as nutritional supplement, olmesartan and valsartan for treating blood pressure, rituximab for treating chronic focal encephalitis and gene-activated glucocerebrosidase for treating Gaucher’s disease, which affects the liver. The five top agencies which funded the clinical trials were the Indian Council of Medical Research, the Department of Bio-technology, the World Health Organisation and the John Hopkins Bloomberg School of Public Health of US. If carefully conducted, clinical trials are the safest and fastest way of inventing treatment. AIIMS report says that the deaths accounted for a mortality rate of 1.18 per cent.

But the ultimate question is the ethical aspect behind treating the babies like guinea pigs. AIIMS claims that before conducting the trials it had obtained clearance from its own Ethics Committee, the Health Ministry’s steering committee on ethics and the National Ethics Committee. Trials were conducted under strict protocol and every step was analysed through faculty presentations and data safety management groups. Then, why foreign countries choose India, avoiding their own population?

AIIMS admits that the families of patients were given social counselling before trials were commenced on them. In some patients, mortality was the normal outcome and AIIMS wanted to ascertain whether the drug (being tested) could improve the situation. But this is not a tenable argument. Most of the patients at AIIMS are illiterate and from extremely poor families. According to Varma, the ‘consent form’ that has to be executed by the parents was read out by the treating physician to the said parents who were not able to read it themselves. In the circumstances, it is debatable whether they understood what ‘clinical trial’ was and what their children were being subjected to. The parents are in a hurry to save their children, something the investors in the trials take advantage of. With the help of doctors they convince the patient’s relatives that the new medicine can save the child if they are permitted to use it on the child. The socio-economic condition of the patient’s family plays a role here. According to the report, the children are drawn from patients who seek out-patient and in-patient services. The eligible patients are chosen, based on the needs of the respective studies. The reasons behind the death of babies, their age or their gender have not been disclosed in the reply furnished by AIIMS because these details were not specifically sought by the applicant. But Varma says that he received an unsatisfactory reply from the paediatrics surgery department. After all, he had separately filed the same set of questions with the paediatrics department and its surgery department. Hence the reply from AIIMS has only given rise to even more doubts. But, at least, a part of what remained hidden has come out in the open now.

In conclusion, for international agencies, India has emerged as the favourable destination to test their products thanks to the ease with which they can enter our country, courtesy our pliant bureaucracy. Hence a nodal agency, along the lines of the Care Prevention Control for Experimental Animals (whose permission has to be sought before using the animals as guinea pigs) is needed badly and promptly. The government should act urgently in the matter to prevent the international mafias from exploiting our poor and illiterate brothers and sisters by conniving with officers of the health sector. Otherwise we may end up as the next guinea pigs when we visit the hospital next time!

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